EP3603708A1 - Needle-equipped outer cylinder and method for manufacturing same - Google Patents
Needle-equipped outer cylinder and method for manufacturing same Download PDFInfo
- Publication number
- EP3603708A1 EP3603708A1 EP18777530.9A EP18777530A EP3603708A1 EP 3603708 A1 EP3603708 A1 EP 3603708A1 EP 18777530 A EP18777530 A EP 18777530A EP 3603708 A1 EP3603708 A1 EP 3603708A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- outer cylinder
- joining member
- needle
- needle tube
- joining
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/343—Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/349—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using adhesive bond or glues
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
- A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/48—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
- B29C65/50—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding using adhesive tape, e.g. thermoplastic tape; using threads or the like
- B29C65/5057—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding using adhesive tape, e.g. thermoplastic tape; using threads or the like positioned between the surfaces to be joined
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7544—Injection needles, syringes
Definitions
- the present invention relates to a needle-equipped outer cylinder in which a needle tube of an injector is directly fixedly joined to a distal end of an injector outer cylinder in advance, a method for manufacturing the same, and a prefilled syringe using the needle-equipped outer cylinder.
- a needle-equipped outer cylinder in which a needle tube of the injector is fixedly joined directly to a distal end of an injector outer cylinder in advance is sometimes used.
- a method for manufacturing such needle-equipped outer cylinder in addition to a method for joining the needle tube to the distal end of the outer cylinder with an adhesive or the like and a method for joining the needle tube to the distal end portion of the outer cylinder by insert molding, a method for heat welding the needle tube to the outer cylinder is known (refer to Patent Literature 1).
- Patent Literature 1 A method in which a cylindrical joining member is interposed between the needle tube and the outer cylinder, and the joining member is press-fitted to the outer cylinder, thereby assembling the three members is also known (refer to Patent Literature 2).
- an outer cylinder of a portion abutting the joining member has a portion which abuts but is a non-heat welded portion.
- crack occurs in the portion which is an abutment portion and the non-heat welded portion after manufacture of the needle-equipped outer cylinder.
- a needle-equipped outer cylinder 1 of Patent Literature 3 includes a needle tube 3, a joining member 4 including a needle insertion hole 42 penetrating from a distal end to a proximal end into which the needle tube 3 is inserted and a tapered portion 47 an outer diameter of which is reduced from a distal end side toward a proximal end side, and an outer cylinder member 2 provided with a distal end joint 22 including a tapered inner cavity 26 capable of receiving the tapered portion 47 of the joining member 4.
- the joining member 4 is inserted into the inner cavity 26 of the distal end joint 22 of the outer cylinder member 2 and is fixed to the distal end joint 22 by a heat welded portion 45 formed in a position on a proximal end side by a predetermined length from a distal end of the distal end joint 22.
- the distal end joint 22 includes a non-welded abutment portion 46 which is a non-heat welded portion and abuts the joining member 4 on a site on the distal end side from the heat welded portion 45.
- the non-welded abutment portion 46 has residual strain and does not have crack.
- Patent Literature 3 The one disclosed in Patent Literature 3 has a sufficient effect.
- the present invention is achieved in view of the above-described problems, and an object thereof is to provide: a needle-equipped outer cylinder including a needle tube, a joining member including a needle tube accommodation hole which penetrates from a distal end to a proximal end into which the needle tube is inserted and a tapered portion an outer diameter of which is reduced from a distal end side toward a proximal end side, and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the tapered portion of the joining member in which the joining member is excellently fixedly joined to the outer cylinder member; a method for manufacturing the same; and a prefilled syringe using the needle-equipped outer cylinder.
- a needle-equipped outer cylinder provided with: a needle tube; a joining member including a needle tube accommodation hole for accommodating a proximal end side portion of the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole; and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member from a distal end side, in which the needle tube accommodation hole penetrates the joining member from a distal end of the joining member to a proximal end of the joining member, the outer cylinder member is provided with a projection provided on a proximal end portion of the inner cavity and projecting in the inner cavity, the joining member is provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion of the joining member, at least the joining outer peripheral portion of the joining member is inserted into the inner cavity of the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection
- a needle-equipped outer cylinder 1 of the present invention is formed of a needle tube 3, a joining member 4 including a needle tube accommodation hole 42 for accommodating a proximal end side portion of the needle tube 3 and a joining outer peripheral portion 47 provided on an outer peripheral portion of the needle tube accommodation hole 42 (in other words, arranged around an axis), and an outer cylinder member 2 provided with a distal end joint 22 including an inner cavity 26 capable of receiving the joining outer peripheral portion of the joining member 4 from a distal end side.
- the needle tube accommodation hole 42 penetrates the joining member 4 from a distal end of the joining member 4 to a proximal end of the joining member 4.
- the outer cylinder member 2 is provided with a projection 28 arranged on a proximal end portion of the inner cavity 26 and projecting in the inner cavity 26, and the joining member 4 is provided with an abutment portion 48 which abuts the projection 28 of the outer cylinder member 2 on a proximal end portion of the joining member 4.
- At least the joining outer peripheral portion 47 of the joining member 4 is inserted into the inner cavity 26 of the distal end joint 22 of the outer cylinder member 2, and the abutment portion 48 of the joining member 4 abuts the projection 28 of the outer cylinder member 2.
- the joining outer peripheral portion 47 of the joining member 4 includes a heat welded portion 45 formed in a position on a proximal end side by a predetermined length from a distal end of the distal end joint 22 of the outer cylinder member 2, and the joining outer peripheral portion 47 of the joining member 4 is fixedly joined to an inner peripheral surface of the distal end joint 22 on an outer peripheral portion of the heat welded portion 45 and is fixedly joined to an outer peripheral surface of the needle tube 3 on an inner peripheral portion of the heat welded portion 45.
- the needle-equipped outer cylinder of the present invention is used for tapping a needle tip from a surface of the skin and injecting medicine solution into a living body.
- the needle-equipped outer cylinder 1 of this example is provided with the needle tube 3, the joining member 4 to which the needle tube 3 is fixedly joined, and the outer cylinder member 2 to which the joining member 4 is fixedly joined. Also, as illustrated in Figs. 10 and 11 , a cap 6 is attached to the needle-equipped outer cylinder 1.
- the needle tube 3 of 27 to 30G (outer diameter: ⁇ 0.41 to 0.31 mm) according to the ISO standards for medical needle tube (ISO9626:1991/Amd.1:2001(E)) is used. Note that, a size of the needle tube 3 may be 26G or larger.
- a needle tip 32 to be tapped into the living body is formed on one end in an axial direction of the needle tube 3.
- the needle tip 32 is formed at an acute angle with a blade surface.
- the needle tube 3 is formed to have a length such that the needle tip 32 thereof projects from a distal end side cylinder portion (distal end portion) 43 to be described later of the joining member 4, and a proximal end 33 of the needle tube 3 on the opposite side of the needle tip 32 projects from the joining outer peripheral portion 47 (in this example, tapered portion) 47 to be described later of the joining member 4 to be arranged in the distal end joint 22 to be described later of the outer cylinder member 2.
- An intermediate portion 31 of the needle tube 3 is inserted into the needle tube accommodation hole 42 to be described later of the joining member 4.
- a surface of at least the intermediate portion 31 in the needle tube 3 is made a rough surface by blasting or the like.
- the needle tube 3 As a material of the needle tube 3, for example, stainless steel is preferable. However, the material is not limited thereto, and aluminum, an aluminum alloy, titanium, a titanium alloy, and other metal may also be used. Also, not only a straight needle but also a tapered needle in which at least a part is tapered may be used as the needle tube 3. A cross-sectional shape of the needle tube 3 is not limited to a circle, but may be a polygon such as a triangle. A coating agent made of, for example, a silicone resin or a fluorine-based resin may be applied to the surface on the needle tip 32 side of the needle tube 3.
- the joining member 4 is formed of the distal end side cylinder portion (distal end portion) 43 and a proximal end side cylinder portion 41 having an outer diameter smaller than that of the distal end side cylinder portion 43 and is longer than the distal end side cylinder portion 43.
- the joining member 4 is provided with the needle tube accommodation hole 42 into which the needle tube 3 is inserted and the joining outer peripheral portion 47 formed on the outer peripheral portion thereof.
- the distal end side cylinder portion 43 is formed into a cylindrical shape having a substantially uniform outer diameter.
- an outer surface of the proximal end side cylinder portion 41 in other words, an outer surface of the joining outer peripheral portion 47 is formed into a tapered shape in which an outer diameter is continuously reduced toward the proximal end side of the joining member 4. Also, a cross-section in a radial direction of the joining outer peripheral portion 47 is formed into a circular shape. Especially, in this embodiment, this is formed into a substantially perfect circular shape.
- the joining member 4 is provided with the abutment portion 48 which abuts the projection 28 provided on the proximal end portion of the inner cavity 26 of the outer cylinder member 2 as described later.
- the abutment portion 48 of the joining member 4 is formed of an annular rib projecting rearward from the proximal end (specifically, a proximal end surface) of the joining member 4.
- the abutment portion may be one or a plurality of ribs which is not annular.
- the abutment portion may be formed of the proximal end surface of the joining member 4 instead of providing the above-described rib.
- the abutment portion may be formed of a projection or an annular concave portion provided on a side portion of the proximal end portion of the joining member 4.
- the joining member 4 includes the needle tube accommodation hole 42 into which the needle tube 3 is inserted.
- the needle tube accommodation hole 42 includes a needle tube accommodating portion 42a for accommodating the proximal end side portion of the needle tube, and a communication hole 42b communicated with the needle tube accommodating portion 42a and surrounded by a needle tube locking portion 49 to be described later.
- a diameter of the needle tube accommodating portion 42a of the needle tube accommodation hole 42 is made larger than the outer diameter of the needle tube 3 by about 0.02 to 0.14 mm, preferably about 0.05 to 0.11 mm.
- a gap with the needle tube 3 may be set as described above.
- an inner diameter of the needle tube accommodating portion 42a is set to 0.46 mm or larger.
- a thickness from an outer surface of the joining member 4 to the needle tube accommodation hole 42 is set to 0.38 to 0.48 mm.
- a distal end side portion of the needle tube accommodation hole 42 (inner portion of the distal end side cylinder portion 43) is an enlarged diameter portion 44, a diameter of which is enlarged as compared with other portions. Furthermore, on a proximal end of the enlarged diameter portion 44, an annular rib 55 that projects gently is formed. There are gentle inclined surfaces around an apex of the annular rib 55. Also, on a proximal end side of the annular rib 55, an annular concave portion 56 is provided.
- the joining member 4 is provided with the needle tube locking portion 49 provided on a proximal end portion of the needle tube accommodation hole 42.
- the proximal end 33 of the needle tube 3 inserted into the joining member 4 abuts the needle tube locking portion 49, and movement in a proximal end direction, in other words, removal from the joining member 4 is restricted. Therefore, a projecting length of the needle tube 3 from the distal end of the joining member 4 is constant.
- the needle tube locking portion 49 is formed of an annular projection which projects from an inner surface of the needle tube accommodating portion 42a of the needle tube accommodation hole 42 of the joining member 4.
- the annular projection has a rising surface directed in a distal end direction with respect to the inner surface of the needle tube accommodating portion 42a.
- the needle tube locking portion 49 may also be provided with, for example, an inclined surface a diameter of which is reduced in the proximal end direction.
- the needle tube locking portion 49 may be one or a plurality ribs that is not annular.
- the needle tube locking portion 49 is provided on the proximal end of the needle tube accommodation hole 42.
- the needle tube locking portion 49 may also be located not on the proximal end of the needle tube accommodation hole 42 but on a distal end side by a predetermined length from the proximal end.
- the needle tube accommodation hole 42 includes the communication hole 42b a diameter of which is smaller than that of the needle tube accommodating portion 42a, surrounded by the needle tube locking portion 49.
- An inner portion of an outer cylinder main body 21 of the outer cylinder member 2 and the needle tube 3 are communicated with each other through the communication hole 42b.
- the diameter of the communication hole 42b is preferably larger than an inner diameter of the needle tube and smaller than the outer diameter of the needle tube.
- Examples of forming materials of the joining member 4 and the outer cylinder member 2 to be described later include, for example, various resins such as polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, butadiene-styrene copolymer, and polyamide (for example, nylon 6, nylon 6 ⁇ 6, nylon 6 ⁇ 10, and nylon 12).
- resins such as polypropylene, cyclic polyolefin, polyester and poly-(4-methylpentene-1) are preferably used. It is preferable that the forming materials of the joining member 4 and the outer cylinder member 2 are substantially transparent in order to secure visibility of the inside.
- the outer cylinder member 2 is provided with the outer cylinder main body 21 filled with the medicine solution and the distal end joint 22 to which the joining member 4 is fixedly joined.
- the outer cylinder main body 21 is formed into a substantially cylindrical shape having an inner accommodating portion.
- a flange 23 is formed on a proximal end side in the axial direction of the outer cylinder main body 21. That is, the outer cylinder member 2 is a syringe outer cylinder member capable of being filled with the medicine solution.
- the distal end joint 22 is formed of a joining member receiving portion 24 continuous to the outer cylinder main body 21 and a distal end side enlarged diameter portion 25 continuous to the joining member receiving portion 24.
- An outer shape of the joining member receiving portion 24 is formed such that a cross-section in a radial direction is substantially cruciform, that is, formed with four ribs extending in the axial direction.
- the inner cavity 26 for receiving the joining outer peripheral portion 47 of the joining member 4 from the distal end side is formed in the joining member receiving portion 24.
- the projection 28 provided on the proximal end portion of the inner cavity 26 is provided.
- the projection 28 is an annular projection projecting from an inner surface of the inner cavity 26.
- the annular projection having a rising surface directed in the distal end direction with respect to the inner surface of the inner cavity 26 as that provided in the outer cylinder member 2 illustrated in Figs. 4, 5 , and 17 is preferable.
- the projection may also be provided with, for example, an inclined surface a diameter of which is reduced in the proximal end direction.
- a through hole is formed in the projection 28.
- the projection may be one or a plurality of ribs that is not annular.
- the projection 28 is provided on a lower end of the inner cavity 26.
- the projection 28 may be located not on the lower end of the inner cavity 26 but on a distal end side by a predetermined length from the lower end.
- a projecting height of the projection 28 from the inner surface (inner surface near the projection) of the inner cavity 26 is preferably 0.03 to 0.35 mm, and more preferably 0.05 to 0.25 mm.
- a projecting end of the projection 28 is preferably located on an inner peripheral side relative to an outer peripheral surface of the proximal end portion of the joining member and on an outer peripheral side relative to an inner peripheral surface of the needle tube locking portion 49 (communication hole 42b).
- the joining outer peripheral portion (tapered portion) 47 of the joining member 4 is formed into substantially the same shape as the tapered shape of the tapered inner cavity 26 of the distal end joint 22 of the outer cylinder member 2. Therefore, the joining outer peripheral portion 47 is formed into a shape which may abut the tapered inner cavity 26 over substantially the entire surface in a state in which the abutment portion 48 (specifically, the proximal end surface) of the joining member 4 abuts the projection 28 of the inner cavity 26 of the outer cylinder member 2 when the joining outer peripheral portion 47 of the joining member 4 is inserted into the inner cavity 26 of the outer cylinder member 2.
- the cross-section in the radial direction of the tapered inner cavity 26 is formed into a circular shape, and especially, in the outer cylinder of this example, this is formed into a substantially perfect circular shape. Also, a thickness of a portion without the external rib of the joining member receiving portion 24 is preferably 0.5 to 2.0 mm, and more preferably 0.7 to 1.3 mm.
- a distal end side cylinder portion accommodating portion 27 communicated with the tapered inner cavity 26 and accommodates the distal end side cylinder portion 43 of the joining member 4 is formed.
- the distal end side cylinder portion accommodating portion 27 is formed to have a diameter larger than that of a distal end of the tapered inner cavity 26.
- Taper angles of the tapered inner cavity 26 and the joining outer peripheral portion 47 of the joining member 4 are not especially limited, but are preferably one to three degrees.
- an inner diameter of the distal end side cylinder portion accommodating portion 27 is substantially the same as or slightly larger than an outer diameter of the distal end side cylinder portion 43 of the joining member 4 so that the distal end side cylinder portion 43 may be accommodated.
- the joining member 4 is provided with the needle tube locking portion 49 provided on the proximal end portion of the needle tube accommodation hole 42.
- an outer cylinder member 2a may be provided with the needle tube locking portion 29.
- a joining member 4a does not have a needle tube locking portion.
- an opening diameter of a proximal end opening of the joining member 4a is larger than an outer diameter of the proximal end 33 of the needle tube 3, and the needle tube 3 inserted into the joining member 4a penetrates the joining member 4a and the proximal end 33 thereof projects from the proximal end opening of the joining member 4a.
- the needle tube locking portion 29 is provided on the proximal end of the inner cavity 26 of the outer cylinder member 2a, and the projecting proximal end 33 of the needle tube 3 abuts the needle tube locking portion 29, so that further movement in the proximal end direction is restricted. Therefore, a projecting length of the needle tube 3 from a distal end of the outer cylinder member 2a is constant.
- the needle tube locking portion 29 is formed of an annular projection which projects from an inner surface of the proximal end portion of the inner cavity 26 of the outer cylinder member 2a. Also, the annular projection having the rising surface directed in the distal end direction with respect to the inner surface of the inner cavity 26 is preferable. By such configuration, an abutment state with the proximal end 33 of the needle tube 3 is stabilized.
- the needle tube locking portion 29 may also be provided with, for example, an inclined surface a diameter of which is reduced in the proximal end direction.
- the needle tube locking portion 29 may also be one or a plurality of ribs which is not annular.
- the needle tube locking portion 29 is provided on the proximal end of the inner cavity 26. However, the needle tube locking portion 29 may also be located not on the proximal end of the inner cavity 26 but on the distal end side from the proximal end by a predetermined length.
- a projection 28a provided on the proximal end portion of the inner cavity 26 of an outer cylinder member 2b may abut the abutment portion 48 of a proximal end portion of the joining member 4a and also abut the proximal end 33 of the needle tube 3.
- a projecting height of the projection 28a is higher than that of the projection 28 of the outer cylinder 1a described above.
- the shape of the outer cylinder main body 21 may also be a hollow square pole shape or hexagonal column shape.
- a material compatible with the forming material of the joining member 4 to be used is preferably selected as the material of the outer cylinder member 2.
- the distal end joint 22 of the outer cylinder member 2 and the joining member 4 are fixedly joined to each other by heat welding. Therefore, the material of the outer cylinder member 2 and the material of the joining member 4 are preferably substantially the same material. As a result, it is possible to obtain an excellent joining property between the distal end joint 22 and the joining member 4 and to firmly fix the distal end joint 22 and the joining member 4. In addition, since a welded portion between the distal end joint 22 and the joining member 4 may be made less noticeable, an appearance of the needle-equipped outer cylinder 1 may be improved.
- the needle-equipped outer cylinder 1 includes the heat welded portion 45 formed in the position on the proximal end side by a predetermined length from the distal end of the distal end joint 22 of the outer cylinder member 2.
- the joining outer peripheral portion of the joining member 4 is melted and solidified in the position on the proximal end side by a predetermined length from the distal end of the distal end joint 22 of the outer cylinder member 2, so that the heat welded portion 45 is formed.
- the joining member 4 is joined to the inner peripheral surface of the distal end joint 22 of the outer cylinder member 2 on the outer peripheral portion of the heat welded portion 45, and is fixedly joined to the outer peripheral surface of the needle tube 3 on the inner peripheral portion of the heat welded portion 45.
- the heat welded portion 45 and the vicinity thereof do not contain air bubbles. Therefore, there is no fragile portion due to the air bubbles.
- the distal end joint 22 includes a non-welded abutment portion 46 which is not heat welded to the joining member 4 but abuts the joining member 4.
- the distal end joint 22 includes the non-welded abutment portion 46 for heating to weld only a site closer to the joining outer peripheral portion 47 of the joining member 4 such that a site closer to the distal end of the joining member 4 is not softened to be deformed as described later.
- the non-welded abutment portion 46 in the outer cylinder desirably has residual strain and does not have crack.
- the one including the non-welded abutment portion 46 which is not heat welded to the joining member 4 but abuts the joining member 4 in which the non-welded abutment portion 46 has the residual strain and does not have the crack may be manufactured by a method for manufacturing the needle-equipped outer cylinder to be described later.
- the non-welded abutment portion 46 preferably has a phase difference in birefringence measurement due to the residual strain, and frequency of occurrence of the phase difference exceeding 800 nm in the birefringence measurement preferably is 1/10 or smaller of the frequency of occurrence of the phase difference smaller than 800 nm. Also, in another representation, it is preferable that an area in which the phase difference is 800 nm or larger in a predetermined area portion of a vertical cross-section of the outer cylinder in the non-welded abutment portion 46 is 10% or smaller.
- phase difference an in-plane birefringence phase difference per unit thickness with respect to incident light in a radial direction of the distal end joint 22 in the site of the non-welded abutment portion 46 is used.
- the phase difference is obtained by using two types of characteristic data of data of retardation (birefringence phase difference) characteristic Re measured by a two-dimensional birefringence measurement device and surface distribution data of an axis (fast axis, slow axis) angle.
- the phase difference (in-plane phase difference) may be measured using a commercially available phase difference measurement device (for example, "WPA-100" manufactured by Photonic Lattice and "KOBRA-21 ADH” manufactured by Oji Scientific Instruments) or the Senarmont method.
- the non-welded abutment portion 46 has the residual strain but does not have a portion with significant strain (for example, the crack or a portion which causes later crack).
- the non-welded abutment portion 46 be free from occurrence of the phase difference exceeding 900 nm in the birefringence measurement.
- an area in which the phase difference is 900 nm or larger in a predetermined area portion of the vertical cross-section of the outer cylinder in the non-welded abutment portion 46 is substantially 0.
- the non-welded abutment portion 46 has a peak of occurrence frequency of the phase difference in the birefringence measurement in a range of 100 nm to 500 nm.
- the prefilled syringe 10 of the present invention is provided with the needle-equipped outer cylinder 1 described above, medicine solution 12 filled in the outer cylinder main body 21 of the outer cylinder 1, a gasket 5 accommodated in the outer cylinder main body 21 and slidable in the outer cylinder main body 21, and a cap 6 attached to the distal end portion of the needle-equipped outer cylinder 1 to seal the needle tip 33 of the needle tube 3.
- the syringe 10 is provided with the needle-equipped outer cylinder 1 described above, the cap 6 attached to the distal end portion of the needle-equipped outer cylinder 1 to seal the needle tip 32 of the needle tube 3, the gasket 5 accommodated in the outer cylinder main body 21 of the needle-equipped outer cylinder 1 and slidable in the outer cylinder main body 21, and a plunger 7 attached to the gasket 5.
- the plunger 7 is provided with a main body 71, a gasket attaching portion 72 formed on a distal end of the main body 71, and a pressing portion 73 provided on a proximal end portion.
- the gasket is also provided with a plunger attaching portion which receives the gasket attaching portion 72 of the plunger 7 to engage with the same.
- the syringe 10 of this example is a prefilled syringe in which the outer cylinder main body 21 of the needle-equipped outer cylinder 1 is filled with the medicine solution 12.
- the cap 6 is formed into a cylindrical shape, a base 61 side in the axial direction is opened, and a distal end in the axial direction is closed.
- the cap 6 is formed of, for example, an elastic member such as rubber or an elastomer.
- the cap 6 is attached to the distal end joint 22 of the outer cylinder member 2 so as to cover the needle tip 32 of the needle tube 3 and the distal end joint 22 of the outer cylinder member 2.
- the needle tube 3 side and the distal end joint 22 are inserted into an inner cavity 62 of the cap 6.
- the cap 6 is provided with a cylindrical covering member 8 attached to an outer side of the cap 6 and engaging with the cap 6.
- an inner diameter of the inner cavity 62 of the cap 6 is formed to be substantially equal to an outer diameter of a distal end side fitting portion (distal end side enlarged diameter portion) 25 of the distal end joint 22 or slightly smaller than the distal end side fitting portion 25. Therefore, when the cap 6 is attached to the distal end joint 22, an outer peripheral surface of the distal end side fitting portion 25 is brought into close contact with an inner peripheral surface of the cap 6. Therefore, a space covering the needle tube 3 projecting from the joining member 4 is sealed by the distal end side fitting portion 25 and the inner peripheral surface of the cap 6. By configuring in this manner, it is possible to prevent bacteria from adhering to the needle tip 32. Also, at the same time, a needle tip holding portion 63 holds the needle tip 32.
- the inner peripheral surface of the cap 6 tightens a constricted portion at a boundary between the distal end side fitting portion (distal end side enlarged diameter portion) 25 and a tapered fitting portion (joining member receiving portion) 24 in the distal end joint 22 by an elastic force thereof. In this manner, the inner peripheral surface of the cap 6 and the constricted portion of the distal end joint 22 engage with each other, and the cap 6 may be prevented from being detached from the distal end joint 22 during conveyance.
- the method for manufacturing the needle-equipped outer cylinder of the present invention is the method for manufacturing the outer cylinder formed of the needle tube 3, the joining member 4 including the needle tube accommodation hole 42 penetrating from the distal end to the proximal end for accommodating the proximal end side portion of the needle tube 3 and the joining outer peripheral portion 47 the outer diameter of which is reduced from the distal end side toward the proximal end side, and the outer cylinder member 2 provided with the distal end joint 22 including the inner cavity 26 capable of receiving the joining outer peripheral portion 47 of the joining member 4 from the distal end side.
- the outer cylinder member 2 that provided with the projection 28 provided on the proximal end portion of the inner cavity 26 is used, and as the joining member 4, that provided with the abutment portion 48 which abuts the projection 28 of the outer cylinder member 2 is used.
- the needle tube 3, the joining member 4, and the outer cylinder member 2 are prepared.
- the needle tube 3 is formed as a desired tubular body by, for example, pressing of flat metal or swaging of a hollow pipe.
- the joining member 4 and the outer cylinder member 2 are formed by injection molding. In this manner, by separately molding the joining member 4 and the outer cylinder member 2, a mold may be made compact and simplified.
- the joining member 4 is inserted into the tapered inner cavity 26 of the distal end joint 22 of the outer cylinder member 2.
- the projection 28 of the outer cylinder member 2 abuts the abutment portion 48 of the joining member 4.
- the inner cavity 26 in the distal end joint 22 of the outer cylinder member 2 is the tapered inner cavity 26
- the proximal end side cylinder portion 41 and the joining outer peripheral portion (tapered portion) 47 of the joining member 4 are brought into a state taper fitted to the tapered inner cavity 26 of the distal end joint 22 or nearly tapered fitted.
- the needle tube 3 is inserted.
- the needle tube 3 is inserted from the proximal end side into the needle tube accommodation hole 42 of the joining member 4, and the needle tube 3 is assembled to the joining member 4 attached to the outer cylinder member 2.
- the needle tube 3 is not inserted into the joining member 4 after the attachment of the joining member 4 to the outer cylinder member 2, but the needle tube 3 is inserted to be fixed to the joining member 4 in advance before the attachment of the joining member 4 to the outer cylinder member 2.
- the needle tube 3 and the joining member 4 may be integrally molded in advance by insert molding.
- the joining member 4 provided with the needle tube locking portion 49 provided on the proximal end portion of the needle tube accommodation hole 42 is used. Therefore, the proximal end 33 of the needle tube 3 inserted into the joining member 4 abuts the needle tube locking portion 49, and movement in the proximal end direction, in other words, removal from the joining member 4 is restricted.
- heating to temperature equal to or lower than a softening point of the forming material of the outer cylinder member 2 is preferable. Especially, it is preferable to heat to temperature near a glass transition point of the forming material of the outer cylinder member 2 or higher and the softening point or lower.
- the needle-equipped outer cylinder 1 after the above-described inserting step is preferably heated so as to be within a heating range of 110°C to 150°C.
- a heating means As a heating means, as illustrated in Fig. 12 , it is preferable to use two halogen heaters 11 arranged so as to be opposite to each other with the outer cylinder member 2 interposed therebetween.
- the use of the halogen heater 11 facilitates local heating of the non-welded abutment portion 46 of the outer cylinder member 2 described above.
- an arrival speed in a depth direction may be increased.
- the preheating step in a short time of 100 W (12 V) ⁇ 2 seconds (S) is possible in order to heat to the above-described heating range.
- a periphery of the distal end joint 22 of the outer cylinder member 2 may be uniformly heated by rotating the needle-equipped outer cylinder 1 about its axis.
- the preheating step is performed on the non-welded abutment portion 46 in this embodiment, the preheating step may also be performed on other sites in which the crack might occur. Alternatively, the preheating step may be performed on the entire distal end joint 22.
- the heating means is not limited to the above-described halogen heater 11, but a means such as a carbon heater and a hot air may also be used.
- a means such as a carbon heater and a hot air may also be used.
- heating is performed at 290°C ⁇ 6 seconds (S) in the booth to 110°C to 150°C.
- the joining member welding step is performed by heat welding the joining member 4 to the distal end joint of the outer cylinder member 2 while pressing the distal end side cylinder portion (distal end portion) 43 of the joining member 4 in the proximal end direction of the joining member 4 by a pressing member 17.
- the pressing is preferably performed while pressing with a pressing force of 4N to 30N in the proximal end direction of the joining member 4.
- the tapered inner cavity 26 of the outer cylinder member 2 and the joining outer peripheral portion (tapered portion) 47 of the joining member 4 are in a state taper fitted or nearly taper fitted in the joining member 4 inserted into the distal end joint 22 of the outer cylinder member 2 and in a state in which the projection 28 of the outer cylinder member 2 abuts the abutment portion 48 of the joining member 4. In this state, the heat welding is performed.
- the pressing member 17 includes an accommodation hole 19 for accommodating the needle tube 3 and a pressing portion 18 for pressing the distal end side cylinder portion 43 of the joining member 4.
- the projection 28 of the outer cylinder member 2 abuts the abutment portion 48 of the joining member 4, so that the pressing force is surely transmitted to the abutment portion of the joining member 4.
- a state of the outer peripheral surface of the joining outer peripheral portion 47 and the tapered inner cavity 26 may be maintained.
- the joining member is surely fixedly joined to the outer cylinder member.
- both the joining outer peripheral portion 47 of the joining member 4 and the inner cavity 26 of the outer cylinder member 2 are tapered, a force to axially compress the resin melted at the time of heating acts, so that the heat welding may be surely performed.
- the heat welding is generated using a semiconductor laser irradiation device 20.
- the semiconductor laser irradiation device 20 applies a laser to the heat welded portion 45 between the joining outer peripheral portion 47 of the joining member 4 and the tapered inner cavity 26 of the outer cylinder member 2.
- the needle tube 3 generates heat and the joining member 4 is heated.
- the joining member 4 is softened and adheres to the needle tube 3 and the distal end joint 22 of the outer cylinder member 2.
- the joining member 4 and the needle tube 3, and the joining member 4 and the distal end joint 22 of the outer cylinder member 2 are fixedly joined by heat welding, and the needle-equipped outer cylinder 1 is manufactured.
- an irradiation range of the semiconductor laser irradiation device is determined such that only a predetermined range of the heat welded portion 45 closer to the proximal end of the joining member 4 is melted so as to prevent the proximal end side cylinder portion 41 of the joining member 4 from softening and having a larger outer diameter than the inner diameter of the opening of the tapered inner cavity 26 and to bring the surfaces of the joining outer peripheral portion 47 and the tapered inner cavity 26 into close contact with each other by the pressing member 17.
- the laser irradiates a thin portion between ribs of the tapered fitting portion 24.
- the heat welded portion 45 may be set in an arbitrary position, thereby controlling flexibility (deflection) of the needle tube.
- the heat welded portion 45 is preferably provided from the vicinity of an intermediate portion to the vicinity of a proximal end of the tapered fitting portion 24 or from the vicinity of an intermediate portion to the vicinity of the proximal end of the joining member 4, and in a case where the deflection is not preferred, the heat welded portion 45 is preferably provided from the vicinity of the intermediate portion to the vicinity of a distal end of the tapered fitting portion 24 or from the vicinity of the intermediate portion to the vicinity of the distal end of the joining member 4.
- an output of the semiconductor laser irradiation device 20 is preferably set to 5 to 20W, and an irradiation time of the laser is preferably set to 1.5 to 2.0 seconds (S). Also, as for the optical system, it is preferable to set a focal diameter to ⁇ 3.0 to 3.5 mm.
- the above-described conditions are those of a case where cyclic polyolefin (COP) is applied as the material of the joining member; it is required to set the condition to obtain appropriate resin temperature in accordance with a characteristic of the resin to be used such that foaming, resin burning, and deformation do not occur.
- the joining member 4 and the needle tube 3, and the joining member 4 and the outer cylinder member 2 are joined by using the semiconductor laser irradiation device 20, so that it is possible to fix the needle tube 3 to the outer cylinder member 2 without using an adhesive.
- a high-frequency induction heating device 16 may be used to cause the heat welding.
- the high-frequency induction heating device 16 is provided with a work coil 15 and a power supply 16a for applying alternating current to the work coil 15.
- alternating current is applied from the power supply 16a to the work coil 15
- a magnetic field is generated around the work coil 15, and eddy current is generated in the needle tube 3.
- the needle tube 3 generates heat and the joining member 4 is heated.
- the joining member 4 is softened and adheres to the needle tube 3 and the distal end joint 22 of the outer cylinder member 2.
- the joining member 4 and the needle tube 3, and the joining member 4 and the distal end joint 22 of the outer cylinder member 2 are fixedly joined by heat welding, and the needle-equipped outer cylinder 1 is manufactured.
- the outer cylinder member 2 and the joining member 4 are of substantially the same material. Substantially the same materials have good compatibility. Note that the materials of the outer cylinder member 2 and the joining member 4 may be different thermoplastic resins having compatibility at the time of melting. To have the compatibility means that thermodynamic mutual solubility is excellent, in other words, this means that both are not separated after curing.
- the outer cylinder member of the needle-equipped outer cylinder is a syringe outer cylinder member which may be filled with the medicine solution.
- the outer cylinder member of the needle-equipped outer cylinder may be a needle hub member attachable to a nozzle portion provided on a distal end portion of a syringe outer cylinder which may be filled with the medicine solution.
- the needle hub member includes an attaching portion which may be attached to the nozzle portion of the syringe outer cylinder on a proximal end portion thereof.
- the needle-equipped outer cylinder using such needle hub member may also be used for tapping the needle tip of the needle tube from the surface of the skin and injecting the medicine solution filled in the syringe outer cylinder into the living body.
- the needle-equipped outer cylinder of the present invention may be manufactured using the needle tube and the joining member integrally molded in advance by insert molding.
- the joining outer peripheral portion of the joining member is melted and solidified in the position on the proximal end side by a predetermined length from the distal end of the distal end joint of the outer cylinder member at the joining member welding step, so that the heat welded portion is formed.
- the joining member is fixedly joined to the inner peripheral surface of the distal end joint of the outer cylinder member by the outer peripheral portion of the heat welded portion, and is fixedly joined to the outer peripheral surface of the needle tube by the inner peripheral portion of the heat welded portion.
- the joining member is a part other than the heat welded portion of the joining outer peripheral portion.
- a needle-equipped outer cylinder of the present invention is as follows.
Abstract
Description
- The present invention relates to a needle-equipped outer cylinder in which a needle tube of an injector is directly fixedly joined to a distal end of an injector outer cylinder in advance, a method for manufacturing the same, and a prefilled syringe using the needle-equipped outer cylinder.
- In a case of an injector with a small volume used for insulin administration, vaccine administration and the like, a needle-equipped outer cylinder in which a needle tube of the injector is fixedly joined directly to a distal end of an injector outer cylinder in advance is sometimes used. As a method for manufacturing such needle-equipped outer cylinder, in addition to a method for joining the needle tube to the distal end of the outer cylinder with an adhesive or the like and a method for joining the needle tube to the distal end portion of the outer cylinder by insert molding, a method for heat welding the needle tube to the outer cylinder is known (refer to Patent Literature 1). A method in which a cylindrical joining member is interposed between the needle tube and the outer cylinder, and the joining member is press-fitted to the outer cylinder, thereby assembling the three members is also known (refer to Patent Literature 2).
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- Patent Literature 1:
JP 2005-342100 A - Patent Literature 2:
JP 2004-154210 A - Patent Literature 3:
WO2014/136239 (US2015-374931 ,EP2965774 ) - In a case of using the joining member as in
Patent Literatures - Also, at the heat welding step, when the entire joining member is heated to a certain level or more, even a site on the distal end side of the joining member not inserted into the tapered inner cavity of the outer cylinder could be softened to be deformed to have an outer diameter larger than an inner diameter of an opening of the tapered inner cavity. When such deformation occurs, the deformed portion cannot enter the tapered inner cavity. For this reason, it becomes difficult to heat weld while pressure bonding the surfaces of the tapered portion and the tapered inner cavity to each other, and it becomes difficult to improve reliability of welding between the joining member and the outer cylinder.
- Therefore, it is desirable to limit a heated range so as to sufficiently heat to ensure heat welding in a portion other than a distal end such as an intermediate portion of the joining member, whereas the site on the distal end side of the joining member is not softened. In such circumstances, an outer cylinder of a portion abutting the joining member has a portion which abuts but is a non-heat welded portion. There has been a problem that crack occurs in the portion which is an abutment portion and the non-heat welded portion after manufacture of the needle-equipped outer cylinder.
- Therefore, the applicant of the present application proposes
Patent Literature 3. - A needle-equipped
outer cylinder 1 ofPatent Literature 3 includes aneedle tube 3, a joiningmember 4 including aneedle insertion hole 42 penetrating from a distal end to a proximal end into which theneedle tube 3 is inserted and atapered portion 47 an outer diameter of which is reduced from a distal end side toward a proximal end side, and anouter cylinder member 2 provided with adistal end joint 22 including a taperedinner cavity 26 capable of receiving thetapered portion 47 of the joiningmember 4. Then, the joiningmember 4 is inserted into theinner cavity 26 of thedistal end joint 22 of theouter cylinder member 2 and is fixed to thedistal end joint 22 by a heat weldedportion 45 formed in a position on a proximal end side by a predetermined length from a distal end of thedistal end joint 22. Thedistal end joint 22 includes anon-welded abutment portion 46 which is a non-heat welded portion and abuts the joiningmember 4 on a site on the distal end side from the heat weldedportion 45. Thenon-welded abutment portion 46 has residual strain and does not have crack. - The one disclosed in
Patent Literature 3 has a sufficient effect. - However, there is a case in which a molding difference occurs in an
outer cylinder member 2 and a joiningmember 4 which are moldings, and in a case where this occurs in the tapered portion of the joining member and the tapered inner cavity of the distal end joint of the outer cylinder, when the joining member is inserted into the distal end joint of the outer cylinder member, it is possible that the joining member is not sufficiently fixed in the distal end joint, and joint between the joining member and the outer cylinder by heat welding is not stable. - The present invention is achieved in view of the above-described problems, and an object thereof is to provide: a needle-equipped outer cylinder including a needle tube, a joining member including a needle tube accommodation hole which penetrates from a distal end to a proximal end into which the needle tube is inserted and a tapered portion an outer diameter of which is reduced from a distal end side toward a proximal end side, and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the tapered portion of the joining member in which the joining member is excellently fixedly joined to the outer cylinder member; a method for manufacturing the same; and a prefilled syringe using the needle-equipped outer cylinder.
- The above-described object is achieved by the following.
- A needle-equipped outer cylinder provided with: a needle tube; a joining member including a needle tube accommodation hole for accommodating a proximal end side portion of the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole; and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member from a distal end side,
in which the needle tube accommodation hole penetrates the joining member from a distal end of the joining member to a proximal end of the joining member,
the outer cylinder member is provided with a projection provided on a proximal end portion of the inner cavity and projecting in the inner cavity, the joining member is provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion of the joining member, at least the joining outer peripheral portion of the joining member is inserted into the inner cavity of the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection of the outer cylinder member, and
the joining outer peripheral portion of the joining member includes a heat welded portion formed in a position on a proximal end side by a predetermined length from a distal end of the distal end joint of the outer cylinder member, the joining outer peripheral portion of the joining member is fixedly joined to an inner peripheral surface of the distal end joint on an outer peripheral portion of the heat welded portion and is fixedly joined to an outer peripheral surface of the needle tube on an inner peripheral portion of the heat welded portion. - In addition, the above-described object is achieved by the following.
- A method for manufacturing a needle-equipped outer cylinder provided with a needle tube, a joining member including a needle tube accommodation hole for accommodating the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole, and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member, the method for manufacturing the needle-equipped outer cylinder provided with:
- a preparing step of preparing the outer cylinder member provided with a projection projecting in the inner cavity on a proximal end portion of the inner cavity, the joining member provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion, and the needle tube;
- an assembling step of assembling the needle tube, the joining member, and the outer cylinder member such that the needle tube is inserted into or inserted to be fixed to the needle tube accommodation hole of the joining member, the joining member is inserted into the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection of the outer cylinder member; and
- a welding step of heat welding the joining outer peripheral portion of the joining member to an inner peripheral surface of the distal end joint of the outer cylinder member and an outer peripheral surface of the needle tube by allowing the needle tube to generate heat by a heat generating device to allow the needle tube to generate heat while pressing a distal end portion of the joining member in a proximal end direction of the joining member by a pressing member.
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Fig. 1 is a front view of a needle-equipped outer cylinder of the present invention. -
Fig. 2 is a cross-sectional view taken along line A-A of the needle-equipped outer cylinder ofFig. 1 . -
Fig. 3 is a plan view of the needle-equipped outer cylinder ofFig. 1 . -
Fig. 4 is an enlarged longitudinal cross-sectional view of a distal end portion of the needle-equipped outer cylinder of the present invention. -
Fig. 5 is a longitudinal cross-sectional view of an outer cylinder member used in the needle-equipped outer cylinder of the present invention. -
Fig. 6 is an enlarged front view of a joining member used in the needle-equipped outer cylinder of the present invention. -
Fig. 7 is a plan view of the joining member ofFig. 6 . -
Fig. 8 is a longitudinal cross-sectional view of the joining member ofFig. 6 . -
Fig. 9 is an exploded perspective view of the needle-equipped outer cylinder of the present invention. -
Fig. 10 is a front view of a prefilled syringe using the needle-equipped outer cylinder of the present invention. -
Fig. 11 is a longitudinal cross-sectional view of the prefilled syringe ofFig. 10 . -
Fig. 12 is an illustrative view for illustrating a preheating step in a method for manufacturing the needle-equipped outer cylinder of the present invention. -
Fig. 13 is an illustrative view for illustrating a joining member welding step in the method for manufacturing the needle-equipped outer cylinder of the present invention. -
Fig. 14 is an illustrative view for illustrating a preheating step in a method for manufacturing a needle-equipped outer cylinder according to another embodiment of the present invention. -
Fig. 15 is an enlarged longitudinal cross-sectional view of a distal end portion of the needle-equipped outer cylinder according to another example of the present invention. -
Fig. 16 is an enlarged longitudinal cross-sectional view of the distal end portion of the needle-equipped outer cylinder according to another example of the present invention. -
Fig. 17 is an enlarged cross-sectional view of the distal end portion of the outer cylinder member illustrated inFig. 5 . - Hereinafter, a needle-equipped outer cylinder of the present invention is described using an embodiment illustrated in the drawings.
- A needle-equipped
outer cylinder 1 of the present invention is formed of aneedle tube 3, a joiningmember 4 including a needletube accommodation hole 42 for accommodating a proximal end side portion of theneedle tube 3 and a joining outerperipheral portion 47 provided on an outer peripheral portion of the needle tube accommodation hole 42 (in other words, arranged around an axis), and anouter cylinder member 2 provided with adistal end joint 22 including aninner cavity 26 capable of receiving the joining outer peripheral portion of the joiningmember 4 from a distal end side. The needletube accommodation hole 42 penetrates the joiningmember 4 from a distal end of the joiningmember 4 to a proximal end of the joiningmember 4. - The
outer cylinder member 2 is provided with aprojection 28 arranged on a proximal end portion of theinner cavity 26 and projecting in theinner cavity 26, and the joiningmember 4 is provided with anabutment portion 48 which abuts theprojection 28 of theouter cylinder member 2 on a proximal end portion of the joiningmember 4. At least the joining outerperipheral portion 47 of the joiningmember 4 is inserted into theinner cavity 26 of thedistal end joint 22 of theouter cylinder member 2, and theabutment portion 48 of the joiningmember 4 abuts theprojection 28 of theouter cylinder member 2. - The joining outer
peripheral portion 47 of the joiningmember 4 includes a heat weldedportion 45 formed in a position on a proximal end side by a predetermined length from a distal end of thedistal end joint 22 of theouter cylinder member 2, and the joining outerperipheral portion 47 of the joiningmember 4 is fixedly joined to an inner peripheral surface of thedistal end joint 22 on an outer peripheral portion of the heat weldedportion 45 and is fixedly joined to an outer peripheral surface of theneedle tube 3 on an inner peripheral portion of the heat weldedportion 45. - The needle-equipped outer cylinder of the present invention is used for tapping a needle tip from a surface of the skin and injecting medicine solution into a living body.
- As illustrated in
Fig. 1 to Fig. 4 , the needle-equippedouter cylinder 1 of this example is provided with theneedle tube 3, the joiningmember 4 to which theneedle tube 3 is fixedly joined, and theouter cylinder member 2 to which the joiningmember 4 is fixedly joined. Also, as illustrated inFigs. 10 and11 , acap 6 is attached to the needle-equippedouter cylinder 1. - As illustrated in
Fig. 1 ,3 , and9 , theneedle tube 3 of 27 to 30G (outer diameter: ϕ0.41 to 0.31 mm) according to the ISO standards for medical needle tube (ISO9626:1991/Amd.1:2001(E)) is used. Note that, a size of theneedle tube 3 may be 26G or larger. - On one end in an axial direction of the
needle tube 3, aneedle tip 32 to be tapped into the living body is formed. Theneedle tip 32 is formed at an acute angle with a blade surface. Theneedle tube 3 is formed to have a length such that theneedle tip 32 thereof projects from a distal end side cylinder portion (distal end portion) 43 to be described later of the joiningmember 4, and aproximal end 33 of theneedle tube 3 on the opposite side of theneedle tip 32 projects from the joining outer peripheral portion 47 (in this example, tapered portion) 47 to be described later of the joiningmember 4 to be arranged in the distal end joint 22 to be described later of theouter cylinder member 2. - An
intermediate portion 31 of theneedle tube 3 is inserted into the needletube accommodation hole 42 to be described later of the joiningmember 4. A surface of at least theintermediate portion 31 in theneedle tube 3 is made a rough surface by blasting or the like. As a result, when theneedle tube 3 and the joiningmember 4 are joined by heat welding, a softened resin enters unevenness of the rough surface of theneedle tube 3 and may improve joining strength between theneedle tube 3 and the joiningmember 4. Also, the softened resin enters the unevenness of the rough surface of theneedle tube 3 and may improve liquid tightness. - As a material of the
needle tube 3, for example, stainless steel is preferable. However, the material is not limited thereto, and aluminum, an aluminum alloy, titanium, a titanium alloy, and other metal may also be used. Also, not only a straight needle but also a tapered needle in which at least a part is tapered may be used as theneedle tube 3. A cross-sectional shape of theneedle tube 3 is not limited to a circle, but may be a polygon such as a triangle. A coating agent made of, for example, a silicone resin or a fluorine-based resin may be applied to the surface on theneedle tip 32 side of theneedle tube 3. - Next, the joining
member 4 is described. - As illustrated in
Figs. 6 to 8 , the joiningmember 4 is formed of the distal end side cylinder portion (distal end portion) 43 and a proximal endside cylinder portion 41 having an outer diameter smaller than that of the distal endside cylinder portion 43 and is longer than the distal endside cylinder portion 43. The joiningmember 4 is provided with the needletube accommodation hole 42 into which theneedle tube 3 is inserted and the joining outerperipheral portion 47 formed on the outer peripheral portion thereof. The distal endside cylinder portion 43 is formed into a cylindrical shape having a substantially uniform outer diameter. In this example, an outer surface of the proximal endside cylinder portion 41, in other words, an outer surface of the joining outerperipheral portion 47 is formed into a tapered shape in which an outer diameter is continuously reduced toward the proximal end side of the joiningmember 4. Also, a cross-section in a radial direction of the joining outerperipheral portion 47 is formed into a circular shape. Especially, in this embodiment, this is formed into a substantially perfect circular shape. - Then, the joining
member 4 is provided with theabutment portion 48 which abuts theprojection 28 provided on the proximal end portion of theinner cavity 26 of theouter cylinder member 2 as described later. In this example, theabutment portion 48 of the joiningmember 4 is formed of an annular rib projecting rearward from the proximal end (specifically, a proximal end surface) of the joiningmember 4. Note that, the abutment portion may be one or a plurality of ribs which is not annular. Furthermore, the abutment portion may be formed of the proximal end surface of the joiningmember 4 instead of providing the above-described rib. Also, the abutment portion may be formed of a projection or an annular concave portion provided on a side portion of the proximal end portion of the joiningmember 4. - The joining
member 4 includes the needletube accommodation hole 42 into which theneedle tube 3 is inserted. The needletube accommodation hole 42 includes a needletube accommodating portion 42a for accommodating the proximal end side portion of the needle tube, and acommunication hole 42b communicated with the needletube accommodating portion 42a and surrounded by a needletube locking portion 49 to be described later. A diameter of the needletube accommodating portion 42a of the needletube accommodation hole 42 is made larger than the outer diameter of theneedle tube 3 by about 0.02 to 0.14 mm, preferably about 0.05 to 0.11 mm. In a case of using the above-describedneedle tube 3 of 27 to 30 G, by setting the diameter of the needletube accommodating portion 42a to 0.43 to 0.45 mm, a gap with theneedle tube 3 may be set as described above. By setting as described above, it is possible to secure the joining strength of theneedle tube 3 after joint and prevent theneedle tube 3 after joint from inclining by a predetermined amount or larger. Note that, in a case where the needle tube of 26 G or larger is used, an inner diameter of the needletube accommodating portion 42a is set to 0.46 mm or larger. - Also, a thickness from an outer surface of the joining
member 4 to the needletube accommodation hole 42 is set to 0.38 to 0.48 mm. By making such joiningmember 4, it is possible to manufacture the needle-equippedouter cylinder 1 by using a single joiningmember 4 and eachneedle tube 3 of 27 to 30 G while securing the joining strength of theneedle tube 3, and preventing theneedle tube 3 after joint from inclining by a predetermined amount or larger. - Also, as illustrated in
Fig. 8 , a distal end side portion of the needle tube accommodation hole 42 (inner portion of the distal end side cylinder portion 43) is anenlarged diameter portion 44, a diameter of which is enlarged as compared with other portions. Furthermore, on a proximal end of theenlarged diameter portion 44, anannular rib 55 that projects gently is formed. There are gentle inclined surfaces around an apex of theannular rib 55. Also, on a proximal end side of theannular rib 55, an annularconcave portion 56 is provided. - Then, in the needle-equipped
outer cylinder 1 of this example, as illustrated inFigs. 4 and8 , the joiningmember 4 is provided with the needletube locking portion 49 provided on a proximal end portion of the needletube accommodation hole 42. As illustrated inFig. 4 , theproximal end 33 of theneedle tube 3 inserted into the joiningmember 4 abuts the needletube locking portion 49, and movement in a proximal end direction, in other words, removal from the joiningmember 4 is restricted. Therefore, a projecting length of theneedle tube 3 from the distal end of the joiningmember 4 is constant. - In this example, the needle
tube locking portion 49 is formed of an annular projection which projects from an inner surface of the needletube accommodating portion 42a of the needletube accommodation hole 42 of the joiningmember 4. In addition, it is preferable that the annular projection has a rising surface directed in a distal end direction with respect to the inner surface of the needletube accommodating portion 42a. By such configuration, an abutment state with theproximal end 33 of theneedle tube 3 is stabilized. However, the needletube locking portion 49 may also be provided with, for example, an inclined surface a diameter of which is reduced in the proximal end direction. The needletube locking portion 49 may be one or a plurality ribs that is not annular. In this example, the needletube locking portion 49 is provided on the proximal end of the needletube accommodation hole 42. However, the needletube locking portion 49 may also be located not on the proximal end of the needletube accommodation hole 42 but on a distal end side by a predetermined length from the proximal end. - In addition, the needle
tube accommodation hole 42 includes thecommunication hole 42b a diameter of which is smaller than that of the needletube accommodating portion 42a, surrounded by the needletube locking portion 49. An inner portion of an outer cylindermain body 21 of theouter cylinder member 2 and theneedle tube 3 are communicated with each other through thecommunication hole 42b. The diameter of thecommunication hole 42b is preferably larger than an inner diameter of the needle tube and smaller than the outer diameter of the needle tube. As a result, when the medicine solution filled in the outer cylindermain body 21 is discharged from theneedle tube 3, the medicine solution may smoothly pass through thecommunication hole 42b. - Examples of forming materials of the joining
member 4 and theouter cylinder member 2 to be described later include, for example, various resins such as polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, butadiene-styrene copolymer, and polyamide (for example,nylon 6,nylon 6·6,nylon 6·10, and nylon 12). Among them, resins such as polypropylene, cyclic polyolefin, polyester and poly-(4-methylpentene-1) are preferably used. It is preferable that the forming materials of the joiningmember 4 and theouter cylinder member 2 are substantially transparent in order to secure visibility of the inside. - Next, the
outer cylinder member 2 is described. - As illustrated in
Fig. 5 , theouter cylinder member 2 is provided with the outer cylindermain body 21 filled with the medicine solution and the distal end joint 22 to which the joiningmember 4 is fixedly joined. The outer cylindermain body 21 is formed into a substantially cylindrical shape having an inner accommodating portion. Aflange 23 is formed on a proximal end side in the axial direction of the outer cylindermain body 21. That is, theouter cylinder member 2 is a syringe outer cylinder member capable of being filled with the medicine solution. - The distal end joint 22 is formed of a joining
member receiving portion 24 continuous to the outer cylindermain body 21 and a distal end side enlargeddiameter portion 25 continuous to the joiningmember receiving portion 24. An outer shape of the joiningmember receiving portion 24 is formed such that a cross-section in a radial direction is substantially cruciform, that is, formed with four ribs extending in the axial direction. Theinner cavity 26 for receiving the joining outerperipheral portion 47 of the joiningmember 4 from the distal end side is formed in the joiningmember receiving portion 24. - Then, the
projection 28 provided on the proximal end portion of theinner cavity 26 is provided. In this example, theprojection 28 is an annular projection projecting from an inner surface of theinner cavity 26. Also, the annular projection having a rising surface directed in the distal end direction with respect to the inner surface of theinner cavity 26 as that provided in theouter cylinder member 2 illustrated inFigs. 4, 5 , and17 is preferable. By such configuration, the abutment state with the abutment portion (proximal end surface) of the joiningmember 4 is stabilized. However, the projection may also be provided with, for example, an inclined surface a diameter of which is reduced in the proximal end direction. A through hole is formed in theprojection 28. Note that the projection may be one or a plurality of ribs that is not annular. In this example, theprojection 28 is provided on a lower end of theinner cavity 26. However, theprojection 28 may be located not on the lower end of theinner cavity 26 but on a distal end side by a predetermined length from the lower end. A projecting height of theprojection 28 from the inner surface (inner surface near the projection) of theinner cavity 26 is preferably 0.03 to 0.35 mm, and more preferably 0.05 to 0.25 mm. Note that a projecting end of theprojection 28 is preferably located on an inner peripheral side relative to an outer peripheral surface of the proximal end portion of the joining member and on an outer peripheral side relative to an inner peripheral surface of the needle tube locking portion 49 (communication hole 42b). As a result, when the medicine solution filled in the outer cylindermain body 21 is discharged from theneedle tube 3, the medicine solution may smoothly pass through the inside of theprojection 28. - Then, in the needle-equipped
outer cylinder 1 of this example, the joining outer peripheral portion (tapered portion) 47 of the joiningmember 4 is formed into substantially the same shape as the tapered shape of the taperedinner cavity 26 of the distal end joint 22 of theouter cylinder member 2. Therefore, the joining outerperipheral portion 47 is formed into a shape which may abut the taperedinner cavity 26 over substantially the entire surface in a state in which the abutment portion 48 (specifically, the proximal end surface) of the joiningmember 4 abuts theprojection 28 of theinner cavity 26 of theouter cylinder member 2 when the joining outerperipheral portion 47 of the joiningmember 4 is inserted into theinner cavity 26 of theouter cylinder member 2. The cross-section in the radial direction of the taperedinner cavity 26 is formed into a circular shape, and especially, in the outer cylinder of this example, this is formed into a substantially perfect circular shape. Also, a thickness of a portion without the external rib of the joiningmember receiving portion 24 is preferably 0.5 to 2.0 mm, and more preferably 0.7 to 1.3 mm. - Then, the tapered shapes of this tapered
inner cavity 26 and joining outerperipheral portion 47 are substantially the same. Also, in the distal end side enlargeddiameter portion 25, a distal end side cylinderportion accommodating portion 27 communicated with the taperedinner cavity 26 and accommodates the distal endside cylinder portion 43 of the joiningmember 4 is formed. The distal end side cylinderportion accommodating portion 27 is formed to have a diameter larger than that of a distal end of the taperedinner cavity 26. Taper angles of the taperedinner cavity 26 and the joining outerperipheral portion 47 of the joiningmember 4 are not especially limited, but are preferably one to three degrees. As illustrated inFig. 4 , an inner diameter of the distal end side cylinderportion accommodating portion 27 is substantially the same as or slightly larger than an outer diameter of the distal endside cylinder portion 43 of the joiningmember 4 so that the distal endside cylinder portion 43 may be accommodated. - Also, in the needle-equipped
outer cylinder 1 of this example, as illustrated inFigs. 4 and8 and described above, the joiningmember 4 is provided with the needletube locking portion 49 provided on the proximal end portion of the needletube accommodation hole 42. However, as is the case with a needle-equippedouter cylinder 1a of an example illustrated inFig. 15 , anouter cylinder member 2a may be provided with the needletube locking portion 29. In theouter cylinder 1a of this example, a joiningmember 4a does not have a needle tube locking portion. Then, an opening diameter of a proximal end opening of the joiningmember 4a is larger than an outer diameter of theproximal end 33 of theneedle tube 3, and theneedle tube 3 inserted into the joiningmember 4a penetrates the joiningmember 4a and theproximal end 33 thereof projects from the proximal end opening of the joiningmember 4a. Then, the needletube locking portion 29 is provided on the proximal end of theinner cavity 26 of theouter cylinder member 2a, and the projectingproximal end 33 of theneedle tube 3 abuts the needletube locking portion 29, so that further movement in the proximal end direction is restricted. Therefore, a projecting length of theneedle tube 3 from a distal end of theouter cylinder member 2a is constant. - In this example, the needle
tube locking portion 29 is formed of an annular projection which projects from an inner surface of the proximal end portion of theinner cavity 26 of theouter cylinder member 2a. Also, the annular projection having the rising surface directed in the distal end direction with respect to the inner surface of theinner cavity 26 is preferable. By such configuration, an abutment state with theproximal end 33 of theneedle tube 3 is stabilized. However, the needletube locking portion 29 may also be provided with, for example, an inclined surface a diameter of which is reduced in the proximal end direction. The needletube locking portion 29 may also be one or a plurality of ribs which is not annular. In this example, the needletube locking portion 29 is provided on the proximal end of theinner cavity 26. However, the needletube locking portion 29 may also be located not on the proximal end of theinner cavity 26 but on the distal end side from the proximal end by a predetermined length. - Furthermore, as is the case with a needle-equipped
outer cylinder 1b of an example illustrated inFig. 16 , aprojection 28a provided on the proximal end portion of theinner cavity 26 of anouter cylinder member 2b may abut theabutment portion 48 of a proximal end portion of the joiningmember 4a and also abut theproximal end 33 of theneedle tube 3. In this case, a projecting height of theprojection 28a is higher than that of theprojection 28 of theouter cylinder 1a described above. - Although the example in which the shape of the outer cylinder
main body 21 is formed into a substantially cylindrical shape is described in this embodiment, the shape of the outer cylindermain body 21 may also be a hollow square pole shape or hexagonal column shape. - A material compatible with the forming material of the joining
member 4 to be used is preferably selected as the material of theouter cylinder member 2. - Especially, as described later, the distal end joint 22 of the
outer cylinder member 2 and the joiningmember 4 are fixedly joined to each other by heat welding. Therefore, the material of theouter cylinder member 2 and the material of the joiningmember 4 are preferably substantially the same material. As a result, it is possible to obtain an excellent joining property between the distal end joint 22 and the joiningmember 4 and to firmly fix the distal end joint 22 and the joiningmember 4. In addition, since a welded portion between the distal end joint 22 and the joiningmember 4 may be made less noticeable, an appearance of the needle-equippedouter cylinder 1 may be improved. -
Such needle tube 3, joiningmember 4, andouter cylinder member 2 are welded by a manufacturing method to be described later to form the needle-equippedouter cylinder 1 as illustrated inFigs. 1 to 4 . As illustrated inFig. 4 , the needle-equippedouter cylinder 1 includes the heat weldedportion 45 formed in the position on the proximal end side by a predetermined length from the distal end of the distal end joint 22 of theouter cylinder member 2. The joining outer peripheral portion of the joiningmember 4 is melted and solidified in the position on the proximal end side by a predetermined length from the distal end of the distal end joint 22 of theouter cylinder member 2, so that the heat weldedportion 45 is formed. Then, the joiningmember 4 is joined to the inner peripheral surface of the distal end joint 22 of theouter cylinder member 2 on the outer peripheral portion of the heat weldedportion 45, and is fixedly joined to the outer peripheral surface of theneedle tube 3 on the inner peripheral portion of the heat weldedportion 45. Then, in the outer cylinder of the present invention, the heat weldedportion 45 and the vicinity thereof do not contain air bubbles. Therefore, there is no fragile portion due to the air bubbles. - Then, in a site on the distal end side from the heat welded
portion 45, the distal end joint 22 includes anon-welded abutment portion 46 which is not heat welded to the joiningmember 4 but abuts the joiningmember 4. In this manner, the distal end joint 22 includes thenon-welded abutment portion 46 for heating to weld only a site closer to the joining outerperipheral portion 47 of the joiningmember 4 such that a site closer to the distal end of the joiningmember 4 is not softened to be deformed as described later. - Then, the
non-welded abutment portion 46 in the outer cylinder desirably has residual strain and does not have crack. Then, the one including thenon-welded abutment portion 46 which is not heat welded to the joiningmember 4 but abuts the joiningmember 4 in which thenon-welded abutment portion 46 has the residual strain and does not have the crack may be manufactured by a method for manufacturing the needle-equipped outer cylinder to be described later. - Furthermore, the
non-welded abutment portion 46 preferably has a phase difference in birefringence measurement due to the residual strain, and frequency of occurrence of the phase difference exceeding 800 nm in the birefringence measurement preferably is 1/10 or smaller of the frequency of occurrence of the phase difference smaller than 800 nm. Also, in another representation, it is preferable that an area in which the phase difference is 800 nm or larger in a predetermined area portion of a vertical cross-section of the outer cylinder in thenon-welded abutment portion 46 is 10% or smaller. - Herein, as the "phase difference", an in-plane birefringence phase difference per unit thickness with respect to incident light in a radial direction of the distal end joint 22 in the site of the
non-welded abutment portion 46 is used. The phase difference is obtained by using two types of characteristic data of data of retardation (birefringence phase difference) characteristic Re measured by a two-dimensional birefringence measurement device and surface distribution data of an axis (fast axis, slow axis) angle. The phase difference (in-plane phase difference) may be measured using a commercially available phase difference measurement device (for example, "WPA-100" manufactured by Photonic Lattice and "KOBRA-21 ADH" manufactured by Oji Scientific Instruments) or the Senarmont method. - If the frequency of occurrence of the phase difference exceeding 800 nm in the birefringence measurement is not larger than 1/10 of the frequency of occurrence of the phase difference smaller than 800 nm, the
non-welded abutment portion 46 has the residual strain but does not have a portion with significant strain (for example, the crack or a portion which causes later crack). - Especially, it is preferable that the
non-welded abutment portion 46 be free from occurrence of the phase difference exceeding 900 nm in the birefringence measurement. In another representation, it is preferable that an area in which the phase difference is 900 nm or larger in a predetermined area portion of the vertical cross-section of the outer cylinder in thenon-welded abutment portion 46 is substantially 0. Furthermore, it is preferable that thenon-welded abutment portion 46 has a peak of occurrence frequency of the phase difference in the birefringence measurement in a range of 100 nm to 500 nm. - Next, a
prefilled syringe 10 using the needle-equippedouter cylinder 1 of the present invention is described. - The
prefilled syringe 10 of the present invention is provided with the needle-equippedouter cylinder 1 described above,medicine solution 12 filled in the outer cylindermain body 21 of theouter cylinder 1, agasket 5 accommodated in the outer cylindermain body 21 and slidable in the outer cylindermain body 21, and acap 6 attached to the distal end portion of the needle-equippedouter cylinder 1 to seal theneedle tip 33 of theneedle tube 3. - As illustrated in
Fig. 10 , thesyringe 10 is provided with the needle-equippedouter cylinder 1 described above, thecap 6 attached to the distal end portion of the needle-equippedouter cylinder 1 to seal theneedle tip 32 of theneedle tube 3, thegasket 5 accommodated in the outer cylindermain body 21 of the needle-equippedouter cylinder 1 and slidable in the outer cylindermain body 21, and aplunger 7 attached to thegasket 5. Theplunger 7 is provided with amain body 71, agasket attaching portion 72 formed on a distal end of themain body 71, and apressing portion 73 provided on a proximal end portion. The gasket is also provided with a plunger attaching portion which receives thegasket attaching portion 72 of theplunger 7 to engage with the same. Thesyringe 10 of this example is a prefilled syringe in which the outer cylindermain body 21 of the needle-equippedouter cylinder 1 is filled with themedicine solution 12. - Then, the
cap 6 is formed into a cylindrical shape, a base 61 side in the axial direction is opened, and a distal end in the axial direction is closed. Thecap 6 is formed of, for example, an elastic member such as rubber or an elastomer. Thecap 6 is attached to the distal end joint 22 of theouter cylinder member 2 so as to cover theneedle tip 32 of theneedle tube 3 and the distal end joint 22 of theouter cylinder member 2. Then, as illustrated inFig. 11 , theneedle tube 3 side and the distal end joint 22 are inserted into aninner cavity 62 of thecap 6. Furthermore, in this example, thecap 6 is provided with acylindrical covering member 8 attached to an outer side of thecap 6 and engaging with thecap 6. - Note that, an inner diameter of the
inner cavity 62 of thecap 6 is formed to be substantially equal to an outer diameter of a distal end side fitting portion (distal end side enlarged diameter portion) 25 of the distal end joint 22 or slightly smaller than the distal end sidefitting portion 25. Therefore, when thecap 6 is attached to the distal end joint 22, an outer peripheral surface of the distal end sidefitting portion 25 is brought into close contact with an inner peripheral surface of thecap 6. Therefore, a space covering theneedle tube 3 projecting from the joiningmember 4 is sealed by the distal end sidefitting portion 25 and the inner peripheral surface of thecap 6. By configuring in this manner, it is possible to prevent bacteria from adhering to theneedle tip 32. Also, at the same time, a needletip holding portion 63 holds theneedle tip 32. - The inner peripheral surface of the
cap 6 tightens a constricted portion at a boundary between the distal end side fitting portion (distal end side enlarged diameter portion) 25 and a tapered fitting portion (joining member receiving portion) 24 in the distal end joint 22 by an elastic force thereof. In this manner, the inner peripheral surface of thecap 6 and the constricted portion of the distal end joint 22 engage with each other, and thecap 6 may be prevented from being detached from the distal end joint 22 during conveyance. - Next, the method for manufacturing the needle-equipped
outer cylinder 1 is described. - The method for manufacturing the needle-equipped outer cylinder of the present invention is the method for manufacturing the outer cylinder formed of the
needle tube 3, the joiningmember 4 including the needletube accommodation hole 42 penetrating from the distal end to the proximal end for accommodating the proximal end side portion of theneedle tube 3 and the joining outerperipheral portion 47 the outer diameter of which is reduced from the distal end side toward the proximal end side, and theouter cylinder member 2 provided with the distal end joint 22 including theinner cavity 26 capable of receiving the joining outerperipheral portion 47 of the joiningmember 4 from the distal end side. - In the method for manufacturing the needle-equipped outer cylinder according to the present invention, as the
outer cylinder member 2, that provided with theprojection 28 provided on the proximal end portion of theinner cavity 26 is used, and as the joiningmember 4, that provided with theabutment portion 48 which abuts theprojection 28 of theouter cylinder member 2 is used. - Then, in the method for manufacturing the needle-equipped outer cylinder according to the present invention, an assembling step at which the
needle tube 3 is inserted into or inserted to be fixed to the needletube accommodation hole 42 of the joiningmember 4, the joiningmember 4 is inserted into the distal end joint 22 of theouter cylinder member 2, and theprojection 28 of theouter cylinder member 2 abuts theabutment portion 48 of the joiningmember 4, and a joining member welding step at which the joiningmember 4 is heat welded to the distal end joint 22 of theouter cylinder member 2 while pressing the distal end portion of the joiningmember 4 in the proximal end direction of the joiningmember 4 by a pressing member are performed. - In order to manufacture the needle-equipped
outer cylinder 1 of the present invention, as illustrated inFig. 9 , theneedle tube 3, the joiningmember 4, and theouter cylinder member 2 are prepared. Theneedle tube 3 is formed as a desired tubular body by, for example, pressing of flat metal or swaging of a hollow pipe. The joiningmember 4 and theouter cylinder member 2 are formed by injection molding. In this manner, by separately molding the joiningmember 4 and theouter cylinder member 2, a mold may be made compact and simplified. - Next, the assembling step of the
needle tube 3 and the joiningmember 4 to the outer cylinder member is performed. - At this assembling step, the joining
member 4 is inserted into the taperedinner cavity 26 of the distal end joint 22 of theouter cylinder member 2. When the joiningmember 4 is pushed to the proximal end in the distal end joint 22, theprojection 28 of theouter cylinder member 2 abuts theabutment portion 48 of the joiningmember 4. Note that, in this example, since theinner cavity 26 in the distal end joint 22 of theouter cylinder member 2 is the taperedinner cavity 26, the proximal endside cylinder portion 41 and the joining outer peripheral portion (tapered portion) 47 of the joiningmember 4 are brought into a state taper fitted to the taperedinner cavity 26 of the distal end joint 22 or nearly tapered fitted. - Then, the
needle tube 3 is inserted. At this inserting step, theneedle tube 3 is inserted from the proximal end side into the needletube accommodation hole 42 of the joiningmember 4, and theneedle tube 3 is assembled to the joiningmember 4 attached to theouter cylinder member 2. Note that, it is also possible that theneedle tube 3 is not inserted into the joiningmember 4 after the attachment of the joiningmember 4 to theouter cylinder member 2, but theneedle tube 3 is inserted to be fixed to the joiningmember 4 in advance before the attachment of the joiningmember 4 to theouter cylinder member 2. Alternatively, theneedle tube 3 and the joiningmember 4 may be integrally molded in advance by insert molding. - In this example, as illustrated in
Figs. 4 and12 , the joiningmember 4 provided with the needletube locking portion 49 provided on the proximal end portion of the needletube accommodation hole 42 is used. Therefore, theproximal end 33 of theneedle tube 3 inserted into the joiningmember 4 abuts the needletube locking portion 49, and movement in the proximal end direction, in other words, removal from the joiningmember 4 is restricted. - It is preferable to perform a preheating step after the assembling step described above and before the joining member welding step to be described later.
- At the preheating step, heating to temperature equal to or lower than a softening point of the forming material of the
outer cylinder member 2 is preferable. Especially, it is preferable to heat to temperature near a glass transition point of the forming material of theouter cylinder member 2 or higher and the softening point or lower. Specifically, in a case of using theouter cylinder member 2 made of cyclic polyolefin (COP) as the forming material, the needle-equippedouter cylinder 1 after the above-described inserting step is preferably heated so as to be within a heating range of 110°C to 150°C. - As a heating means, as illustrated in
Fig. 12 , it is preferable to use twohalogen heaters 11 arranged so as to be opposite to each other with theouter cylinder member 2 interposed therebetween. The use of thehalogen heater 11 facilitates local heating of thenon-welded abutment portion 46 of theouter cylinder member 2 described above. In addition, an arrival speed in a depth direction may be increased. As for an example of the above-described needle-equippedouter cylinder 1, the preheating step in a short time of 100 W (12 V) × 2 seconds (S) is possible in order to heat to the above-described heating range. At the preheating step, a periphery of the distal end joint 22 of theouter cylinder member 2 may be uniformly heated by rotating the needle-equippedouter cylinder 1 about its axis. Note that, although the preheating step is performed on thenon-welded abutment portion 46 in this embodiment, the preheating step may also be performed on other sites in which the crack might occur. Alternatively, the preheating step may be performed on the entire distal end joint 22. - Also, the heating means is not limited to the above-described
halogen heater 11, but a means such as a carbon heater and a hot air may also be used. For example, in a case where the needle-equippedouter cylinder 1 is heated with hot air in a booth, for example, in the needle-equippedouter cylinder 1 having the same configuration as that described above, heating is performed at 290°C × 6 seconds (S) in the booth to 110°C to 150°C. - Next, after the above-described preheating step, the joining member welding step is performed. As illustrated in
Fig. 13 , the joining member welding step is performed by heat welding the joiningmember 4 to the distal end joint of theouter cylinder member 2 while pressing the distal end side cylinder portion (distal end portion) 43 of the joiningmember 4 in the proximal end direction of the joiningmember 4 by a pressingmember 17. The pressing is preferably performed while pressing with a pressing force of 4N to 30N in the proximal end direction of the joiningmember 4. - As described above, the tapered
inner cavity 26 of theouter cylinder member 2 and the joining outer peripheral portion (tapered portion) 47 of the joiningmember 4 are in a state taper fitted or nearly taper fitted in the joiningmember 4 inserted into the distal end joint 22 of theouter cylinder member 2 and in a state in which theprojection 28 of theouter cylinder member 2 abuts theabutment portion 48 of the joiningmember 4. In this state, the heat welding is performed. - The pressing
member 17 includes anaccommodation hole 19 for accommodating theneedle tube 3 and apressing portion 18 for pressing the distal endside cylinder portion 43 of the joiningmember 4. When pressure is applied to the joiningmember 4 by thepressing portion 18, theprojection 28 of theouter cylinder member 2 abuts theabutment portion 48 of the joiningmember 4, so that the pressing force is surely transmitted to the abutment portion of the joiningmember 4. Then, at the joining member welding step, a state of the outer peripheral surface of the joining outerperipheral portion 47 and the taperedinner cavity 26 may be maintained. Then, by heating and partial melting of the joiningmember 4, the joining member is surely fixedly joined to the outer cylinder member. Especially, in this example, since both the joining outerperipheral portion 47 of the joiningmember 4 and theinner cavity 26 of theouter cylinder member 2 are tapered, a force to axially compress the resin melted at the time of heating acts, so that the heat welding may be surely performed. - In this embodiment, the heat welding is generated using a semiconductor
laser irradiation device 20. The semiconductorlaser irradiation device 20 applies a laser to the heat weldedportion 45 between the joining outerperipheral portion 47 of the joiningmember 4 and the taperedinner cavity 26 of theouter cylinder member 2. As a result, theneedle tube 3 generates heat and the joiningmember 4 is heated. Then, the joiningmember 4 is softened and adheres to theneedle tube 3 and the distal end joint 22 of theouter cylinder member 2. As a result, the joiningmember 4 and theneedle tube 3, and the joiningmember 4 and the distal end joint 22 of theouter cylinder member 2 are fixedly joined by heat welding, and the needle-equippedouter cylinder 1 is manufactured. - Note that, an irradiation range of the semiconductor laser irradiation device is determined such that only a predetermined range of the heat welded
portion 45 closer to the proximal end of the joiningmember 4 is melted so as to prevent the proximal endside cylinder portion 41 of the joiningmember 4 from softening and having a larger outer diameter than the inner diameter of the opening of the taperedinner cavity 26 and to bring the surfaces of the joining outerperipheral portion 47 and the taperedinner cavity 26 into close contact with each other by the pressingmember 17. At that time, the laser irradiates a thin portion between ribs of the taperedfitting portion 24. - Also, the heat welded
portion 45 may be set in an arbitrary position, thereby controlling flexibility (deflection) of the needle tube. For example, in a case where occurrence of kink (break) is prevented by making the needle tube easy to bend, the heat weldedportion 45 is preferably provided from the vicinity of an intermediate portion to the vicinity of a proximal end of the taperedfitting portion 24 or from the vicinity of an intermediate portion to the vicinity of the proximal end of the joiningmember 4, and in a case where the deflection is not preferred, the heat weldedportion 45 is preferably provided from the vicinity of the intermediate portion to the vicinity of a distal end of the taperedfitting portion 24 or from the vicinity of the intermediate portion to the vicinity of the distal end of the joiningmember 4. - Note that, in a case where a thickness of the joining
member 4 is set to 0.38 to 0.48 mm, and a thickness of a portion without the ribs of the taperedfitting portion 24 of the outer cylinder is set to 0.8 to 1.1 mm, an output of the semiconductorlaser irradiation device 20 is preferably set to 5 to 20W, and an irradiation time of the laser is preferably set to 1.5 to 2.0 seconds (S). Also, as for the optical system, it is preferable to set a focal diameter to ϕ 3.0 to 3.5 mm. The above-described conditions are those of a case where cyclic polyolefin (COP) is applied as the material of the joining member; it is required to set the condition to obtain appropriate resin temperature in accordance with a characteristic of the resin to be used such that foaming, resin burning, and deformation do not occur. In this embodiment, the joiningmember 4 and theneedle tube 3, and the joiningmember 4 and theouter cylinder member 2 are joined by using the semiconductorlaser irradiation device 20, so that it is possible to fix theneedle tube 3 to theouter cylinder member 2 without using an adhesive. - It is also possible to use not only the semiconductor
laser irradiation device 20 at the joining member welding step of the above-described embodiment but also another welding means. For example, as in another embodiment illustrated inFig. 14 , a high-frequencyinduction heating device 16 may be used to cause the heat welding. The high-frequencyinduction heating device 16 is provided with awork coil 15 and apower supply 16a for applying alternating current to thework coil 15. When the alternating current is applied from thepower supply 16a to thework coil 15, a magnetic field is generated around thework coil 15, and eddy current is generated in theneedle tube 3. As a result, theneedle tube 3 generates heat and the joiningmember 4 is heated. Then, the joiningmember 4 is softened and adheres to theneedle tube 3 and the distal end joint 22 of theouter cylinder member 2. As a result, the joiningmember 4 and theneedle tube 3, and the joiningmember 4 and the distal end joint 22 of theouter cylinder member 2 are fixedly joined by heat welding, and the needle-equippedouter cylinder 1 is manufactured. - Also, in the above-described embodiment, the
outer cylinder member 2 and the joiningmember 4 are of substantially the same material. Substantially the same materials have good compatibility. Note that the materials of theouter cylinder member 2 and the joiningmember 4 may be different thermoplastic resins having compatibility at the time of melting. To have the compatibility means that thermodynamic mutual solubility is excellent, in other words, this means that both are not separated after curing. - Also, in the above-described embodiment, the outer cylinder member of the needle-equipped outer cylinder is a syringe outer cylinder member which may be filled with the medicine solution. Note that the outer cylinder member of the needle-equipped outer cylinder may be a needle hub member attachable to a nozzle portion provided on a distal end portion of a syringe outer cylinder which may be filled with the medicine solution. In this case, the needle hub member includes an attaching portion which may be attached to the nozzle portion of the syringe outer cylinder on a proximal end portion thereof. The needle-equipped outer cylinder using such needle hub member may also be used for tapping the needle tip of the needle tube from the surface of the skin and injecting the medicine solution filled in the syringe outer cylinder into the living body.
- In addition, the needle-equipped outer cylinder of the present invention may be manufactured using the needle tube and the joining member integrally molded in advance by insert molding. In this case also, the joining outer peripheral portion of the joining member is melted and solidified in the position on the proximal end side by a predetermined length from the distal end of the distal end joint of the outer cylinder member at the joining member welding step, so that the heat welded portion is formed. Then, the joining member is fixedly joined to the inner peripheral surface of the distal end joint of the outer cylinder member by the outer peripheral portion of the heat welded portion, and is fixedly joined to the outer peripheral surface of the needle tube by the inner peripheral portion of the heat welded portion. Note that, in this case, the joining member is a part other than the heat welded portion of the joining outer peripheral portion.
- A needle-equipped outer cylinder of the present invention is as follows.
- (1) A needle-equipped outer cylinder provided with: a needle tube; a joining member including a needle tube accommodation hole for accommodating a proximal end side portion of the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole; and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member from a distal end side,
in which the needle tube accommodation hole penetrates the joining member from a distal end of the joining member to a proximal end of the joining member,
the outer cylinder member is provided with a projection provided on a proximal end portion of the inner cavity and projecting in the inner cavity, the joining member is provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion of the joining member, at least the joining outer peripheral portion of the joining member is inserted into the inner cavity of the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection of the outer cylinder member, and
the joining outer peripheral portion of the joining member includes a heat welded portion formed in a position on a proximal end side by a predetermined length from a distal end of the distal end joint of the outer cylinder member, the joining outer peripheral portion of the joining member is fixedly joined to an inner peripheral surface of the distal end joint on an outer peripheral portion of the heat welded portion and is fixedly joined to an outer peripheral surface of the needle tube on an inner peripheral portion of the heat welded portion.
This needle-equipped outer cylinder in which the joining member is fixedly joined to the outer cylinder member excellently may be used effectively.
Also, the above-described embodiment may be as follows. - (2) The needle-equipped outer cylinder according to (1) described above, in which the abutment portion of the joining member is formed of a rib extending in a proximal end direction formed on the proximal end of the joining member.
- (3) The needle-equipped outer cylinder according to (1) described above, in which the abutment portion of the joining member is formed of a proximal end surface of the joining member.
- (4) The needle-equipped outer cylinder according to any one of (1) to (3) described above, in which the joining member is provided with a needle tube locking portion provided on a proximal end portion of the needle tube accommodation hole to lock a proximal end of the needle tube.
- (5) The needle-equipped outer cylinder according to any one of (1) to (3) described above, in which the outer cylinder member is provided with a needle tube locking portion provided on the proximal end portion of the inner cavity to lock a proximal end of the needle tube.
- (6) The needle-equipped outer cylinder according to any one of (1) to (5) described above, in which the joining outer peripheral portion of the joining member is a tapered portion an outer diameter of which is reduced from a distal end toward a proximal end of the joining outer peripheral portion, and the inner cavity of the outer cylinder member is a tapered inner cavity a diameter of which is reduced toward a proximal end of the outer cylinder member.
- (7) The needle-equipped outer cylinder according to any one of (1) to (6) described above, in which the distal end joint of the outer cylinder includes a non-welded abutment portion which is not heat welded to the joining member but abuts the joining member in a site on a distal end side from the heat welded portion of the joining member, and the non-welded abutment portion has residual strain but no crack.
- (8) The needle-equipped outer cylinder according to any one of (1) to (7) described above, in which a forming material of the joining member and a forming material of the outer cylinder member are thermoplastic resins having compatibility at the time of melting.
- (9) The needle-equipped outer cylinder according to any one of (1) to (8) described above, in which the outer cylinder member is a syringe outer cylinder member including an outer cylinder main body capable of being filled with medicine solution.
- (10) The needle-equipped outer cylinder according to any one of (1) to (8) described above, in which the outer cylinder member is a needle hub member including an attaching portion attachable to a nozzle portion provided on a distal end portion of a syringe outer cylinder.
A prefilled syringe of the present invention is as follows. - (11) A prefilled syringe provided with: the needle-equipped outer cylinder according to (9) described above; the medicine solution filled in the outer cylinder main body; a gasket accommodated in the outer cylinder main body and slidable in the outer cylinder main body; and a cap attached to a distal end portion of the needle-equipped outer cylinder to seal a needle tip of the needle tube.
This prefilled syringe in which the joining member is fixedly joined to the outer cylinder member excellently also may be used effectively.
A method for manufacturing a needle-equipped outer cylinder of the present invention is as follows. - (12) A method for manufacturing a needle-equipped outer cylinder provided with a needle tube, a joining member including a needle tube accommodation hole for accommodating the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole, and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member, the method for manufacturing the needle-equipped outer cylinder provided with:
- a preparing step of preparing the outer cylinder member provided with a projection projecting in the inner cavity on a proximal end portion of the inner cavity, the joining member provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion, and the needle tube;
- an assembling step of assembling the needle tube, the joining member, and the outer cylinder member such that the needle tube is inserted into or inserted to be fixed to the needle tube accommodation hole of the joining member, the joining member is inserted into the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection of the outer cylinder member; and
- a welding step of heat welding the joining outer peripheral portion of the joining member to an inner peripheral surface of the distal end joint of the outer cylinder member and an outer peripheral surface of the needle tube by allowing the needle tube to generate heat by a heat generating device to allow the needle tube to generate heat while pressing a distal end portion of the joining member in a proximal end direction of the joining member by a pressing member.
In this manufacturing method, the joining member is heat welded to the distal end joint of the outer cylinder member while pressing the distal end portion of the joining member in the proximal end direction of the joining member by the pressing member in a state in which a lower end of the joining member abuts the projection provided on the proximal end portion of the inner cavity of the outer cylinder member, so that it is possible to apply sufficient pressure to the melted resin and the joining member is fixedly joined to the outer cylinder member excellently.
Also, the above-described embodiment may be as follows. - (13) The method for manufacturing the needle-equipped outer cylinder according to (12) described above, in which the joining member is provided with a needle tube locking portion provided on a proximal end portion of the needle tube accommodation hole for locking a proximal end of the needle tube, and locks the proximal end of the needle tube inserted into the needle tube accommodation hole of the joining member at the assembling step by the needle tube locking portion.
- (14) The method for manufacturing the needle-equipped outer cylinder according to (12) or (13) described above, in which a forming material of the joining member and a forming material of the outer cylinder member are thermoplastic resins having compatibility at the time of melting.
Claims (14)
- A needle-equipped outer cylinder comprising: a needle tube; a joining member including a needle tube accommodation hole for accommodating a proximal end side portion of the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole; and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member from a distal end side,
wherein the needle tube accommodation hole penetrates the joining member from a distal end of the joining member to a proximal end of the joining member,
the outer cylinder member is provided with a projection provided on a proximal end portion of the inner cavity and projecting in the inner cavity, the joining member is provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion of the joining member, at least the joining outer peripheral portion of the joining member is inserted into the inner cavity of the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection of the outer cylinder member, and
the joining outer peripheral portion of the joining member includes a heat welded portion formed in a position on a proximal end side by a predetermined length from a distal end of the distal end joint of the outer cylinder member, the joining outer peripheral portion of the joining member is fixedly joined to an inner peripheral surface of the distal end joint on an outer peripheral portion of the heat welded portion and is fixedly joined to an outer peripheral surface of the needle tube on an inner peripheral portion of the heat welded portion. - The needle-equipped outer cylinder according to claim 1, wherein the abutment portion of the joining member is formed of a rib extending in a proximal end direction formed on the proximal end of the joining member.
- The needle-equipped outer cylinder according to claim 1, wherein the abutment portion of the joining member is formed of a proximal end surface of the joining member.
- The needle-equipped outer cylinder according to any one of claim 1 to 3, wherein the joining member is provided with a needle tube locking portion provided on a proximal end portion of the needle tube accommodation hole to lock a proximal end of the needle tube.
- The needle-equipped outer cylinder according to any one of claim 1 to 3, wherein the outer cylinder member is provided with a needle tube locking portion provided on the proximal end portion of the inner cavity to lock a proximal end of the needle tube.
- The needle-equipped outer cylinder according to any one of claims 1 to 5, wherein the joining outer peripheral portion of the joining member is a tapered portion an outer diameter of which is reduced from a distal end toward a proximal end of the joining outer peripheral portion, and the inner cavity of the outer cylinder member is a tapered inner cavity a diameter of which is reduced toward a proximal end of the outer cylinder member.
- The needle-equipped outer cylinder according to any one of claims 1 to 6, wherein the distal end joint of the outer cylinder includes a non-welded abutment portion which is not heat welded to the joining member but abuts the joining member in a site on a distal end side from the heat welded portion of the joining member, and the non-welded abutment portion has residual strain but no crack.
- The needle-equipped outer cylinder according to any one of claims 1 to 7, wherein a forming material of the joining member and a forming material of the outer cylinder member are thermoplastic resins having compatibility at the time of melting.
- The needle-equipped outer cylinder according to any one of claims 1 to 8, wherein the outer cylinder member is a syringe outer cylinder member including an outer cylinder main body capable of being filled with medicine solution.
- The needle-equipped outer cylinder according to any one of claims 1 to 8, wherein the outer cylinder member is a needle hub member including an attaching portion attachable to a nozzle portion provided on a distal end portion of a syringe outer cylinder.
- A prefilled syringe comprising: the needle-equipped outer cylinder according to claim 9; the medicine solution filled in the outer cylinder main body; a gasket accommodated in the outer cylinder main body and slidable in the outer cylinder main body; and a cap attached to a distal end portion of the needle-equipped outer cylinder to seal a needle tip of the needle tube.
- A method for manufacturing a needle-equipped outer cylinder provided with a needle tube, a joining member including a needle tube accommodation hole for accommodating the needle tube and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube accommodation hole, and an outer cylinder member provided with a distal end joint including an inner cavity capable of receiving the joining outer peripheral portion of the joining member, the method for manufacturing the needle-equipped outer cylinder comprising:a preparing step of preparing the outer cylinder member provided with a projection projecting in the inner cavity on a proximal end portion of the inner cavity, the joining member provided with an abutment portion which abuts the projection of the outer cylinder member on a proximal end portion, and the needle tube;an assembling step of assembling the needle tube, the joining member, and the outer cylinder member such that the needle tube is inserted into or inserted to be fixed to the needle tube accommodation hole of the joining member, the joining member is inserted into the distal end joint of the outer cylinder member, and the abutment portion of the joining member abuts the projection of the outer cylinder member; anda welding step of heat welding the joining outer peripheral portion of the joining member to an inner peripheral surface of the distal end joint of the outer cylinder member and an outer peripheral surface of the needle tube by allowing the needle tube to generate heat by a heat generating device to allow the needle tube to generate heat while pressing a distal end portion of the joining member in a proximal end direction of the joining member by a pressing member.
- The method for manufacturing the needle-equipped outer cylinder according to claim 12, wherein the joining member is provided with a needle tube locking portion provided on a proximal end portion of the needle tube accommodation hole for locking a proximal end of the needle tube, and locks the proximal end of the needle tube inserted into the needle tube accommodation hole of the joining member at the assembling step by the needle tube locking portion.
- The method for manufacturing the needle-equipped outer cylinder according to claim 12 or 13, wherein a forming material of the joining member and a forming material of the outer cylinder member are thermoplastic resins having compatibility at the time of melting.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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JP2017071528 | 2017-03-31 | ||
PCT/JP2018/010345 WO2018180566A1 (en) | 2017-03-31 | 2018-03-15 | Needle-equipped outer cylinder and method for manufacturing same |
Publications (2)
Publication Number | Publication Date |
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EP3603708A1 true EP3603708A1 (en) | 2020-02-05 |
EP3603708A4 EP3603708A4 (en) | 2020-09-09 |
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Application Number | Title | Priority Date | Filing Date |
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EP18777530.9A Withdrawn EP3603708A4 (en) | 2017-03-31 | 2018-03-15 | Needle-equipped outer cylinder and method for manufacturing same |
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US (1) | US11590287B2 (en) |
EP (1) | EP3603708A4 (en) |
JP (1) | JPWO2018180566A1 (en) |
CN (1) | CN110475575A (en) |
WO (1) | WO2018180566A1 (en) |
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JP2022543122A (en) * | 2019-08-02 | 2022-10-07 | ノードソン コーポレーション | Dispense tip and method for manufacturing a dispense tip |
Family Cites Families (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3728184A (en) * | 1970-04-29 | 1973-04-17 | Burron Medical Prod Inc | Method of making syringe and needle adapter assembly by ultrasonic bonding |
JP2527703B2 (en) * | 1993-03-12 | 1996-08-28 | 嘉邦 斎藤 | Syringe and method of assembling syringe |
DE69419959T2 (en) * | 1993-03-12 | 2000-08-17 | Yoshikuni Saito | Retractable needle syringe |
US6746428B2 (en) * | 2001-02-21 | 2004-06-08 | Becton, Dickinson And Company | High temperature dry heat sterilizable syringe barrel and needle cannula assembly |
JP2004154210A (en) * | 2002-11-05 | 2004-06-03 | Enomoto Co Ltd | Medical instrument, animal treating instrument and their manufacturing method |
JP2005342100A (en) | 2004-06-01 | 2005-12-15 | Techno Medica Co Ltd | Blood-collecting holder with blood-collecting needle for vacuum blood-collecting tube |
US20080187697A1 (en) * | 2005-03-08 | 2008-08-07 | Masaaki Amano | Structure and Method for Bonding Two Members, Gas Container and Method for Manufacturing Such Gas Container |
JP2006247892A (en) * | 2005-03-08 | 2006-09-21 | Toyota Motor Corp | Joining structure of two members, joining method of them, gas container and its manufacturing method |
JP4949708B2 (en) * | 2006-03-22 | 2012-06-13 | 浜松ホトニクス株式会社 | Resin member joining method |
DE102010045095B4 (en) * | 2010-09-13 | 2015-01-08 | Schott Ag | Syringe body-cannula composite and method for its production |
WO2013065370A1 (en) * | 2011-11-02 | 2013-05-10 | テルモ株式会社 | Method for manufacturing needle-equipped outer tube, and needle-equipped outer tube |
JP6193355B2 (en) * | 2013-03-07 | 2017-09-06 | テルモ株式会社 | Manufacturing method of outer cylinder with needle and outer cylinder with needle |
WO2015064299A1 (en) * | 2013-11-03 | 2015-05-07 | テルモ株式会社 | Needle-eqiupped sysringe, pre-filled syringe, and medical liquid administration device using same |
-
2018
- 2018-03-15 EP EP18777530.9A patent/EP3603708A4/en not_active Withdrawn
- 2018-03-15 JP JP2019509264A patent/JPWO2018180566A1/en active Pending
- 2018-03-15 CN CN201880022898.9A patent/CN110475575A/en active Pending
- 2018-03-15 WO PCT/JP2018/010345 patent/WO2018180566A1/en active Application Filing
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2019
- 2019-09-27 US US16/586,190 patent/US11590287B2/en active Active
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CN110475575A (en) | 2019-11-19 |
US20200023133A1 (en) | 2020-01-23 |
WO2018180566A1 (en) | 2018-10-04 |
US11590287B2 (en) | 2023-02-28 |
EP3603708A4 (en) | 2020-09-09 |
JPWO2018180566A1 (en) | 2020-02-06 |
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